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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/22/2025 Biocompatibility 2-311 Complete ISO 10993-4 Third edition 2017-04 [Including AMD1:2025] Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood [Including Amendment 1 (2025)]
12/23/2024 Anesthesiology 1-187 Complete ISO 80601-2-12 Third edition 2023-11 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
07/15/2019 Anesthesiology 1-144 Complete ISO 80601-2-80 First edition 2018-07 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
05/26/2025 Radiology 12-381 Complete IEC 60601-2-68 Edition 2.0 2025-02 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
12/19/2022 Anesthesiology 1-160 Complete ISO 80601-2-84 First edition 2020-07 Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
07/06/2020 Anesthesiology 1-146 Complete ISO 80601-2-12 Second edition 2020-02 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
05/26/2025 Anesthesiology 1-196 Complete ISO 80601-2-90 First edition 2021-08 Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
12/22/2025 Anesthesiology 1-199 Complete ISO 80601-2-70 Third edition 2025-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
12/23/2024 Anesthesiology 1-188 Complete ISO 80601-2-84 Second edition 2023-11 Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
05/29/2023 General Plastic Surgery/
General Hospital		 6-489 Complete IEC 60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
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